NCT06319040

Brief Summary

Meniscal tears and RAMP lesions are frequently seen together with ACL injuries. The aim of this study was to evaluate the effects of meniscus repair and RAMP lesion repair ACL reconstruction surgery in terms of muscle strength, proprioception, and balance. In our study, the clinical outcomes of both anterior cruciate ligament reconstruction (ACLR), medial meniscus repair (MR) and RAMP lesion repair (RR) have been compared with those of isolated ACLR.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 13, 2024

Last Update Submit

March 13, 2024

Conditions

Keywords

ramp lesionmuscle strengthbalanceproprioceptionACL

Outcome Measures

Primary Outcomes (1)

  • muscle strength measurement

    The isokinetic system (Cybex NORM®, Humac, CA, USA) was used to assess muscle strength measurement. Subjects sat upright on the dynamometer chair with 90˚ hip flexion during measurement. The axis of rotation of the dynamometer was adjusted to align with the anatomical axis of the knee joint (lateral condyle of the femur). To prevent compensatory movements during the test, participants were fixed on both shoulders, waist, and thighs. The belt used for the tested extremity was placed 3 cm proximal to the malleolus. Both verbal and visual feedback was given for individuals to participate in the test with maximum effort

    30 minutes

Study Arms (3)

Study Group 1

15 patients who underwent isolated ACLR

Other: Muscle strength measurementOther: Knee joint proprioceptionOther: BalanceOther: Fall risk testOther: Tegner Activity LevelOther: Lysholm Knee Scoring Scale

Study Group 2

15 patients who underwent ACLR with additional intervention

Other: Muscle strength measurementOther: Knee joint proprioceptionOther: BalanceOther: Fall risk testOther: Tegner Activity LevelOther: Lysholm Knee Scoring Scale

Control Group

15 healthy individuals

Other: Muscle strength measurementOther: Knee joint proprioceptionOther: BalanceOther: Fall risk testOther: Tegner Activity LevelOther: Lysholm Knee Scoring Scale

Interventions

Muscle strength of both legs, maximal reciprocal concentric isokinetic knee extension (quadriceps) and flexion (hamstring) at 60°/s, 90°/s and 180°/s speeds were evaluated

Control GroupStudy Group 1Study Group 2

Knee joint proprioception was assessed by joint position sense. Joint position sense was measured by the previously taught ability to actively find joint position (EPAB)

Control GroupStudy Group 1Study Group 2
BalanceOTHER

The patients and healthy individuals participating in our study were evaluated with the General Stability Index (GSI) for general balance ability, Anterior-Posterior Stability Index (APSI) for anterior-posterior balance ability, Medial-Lateral Stability Index (MLSI) for lateral balance ability and Fall Risk Index (DRI) and Biodex Balance System (Biodex Inc., Shirley, New York, USA) for fall risk. High values obtained indicate deterioration in balance and increased risk of falling.

Control GroupStudy Group 1Study Group 2

Biodex Balance System (Biodex Inc., Shirley, New York, USA) for fall risk

Control GroupStudy Group 1Study Group 2

Tegner Activity Level and the Turkish version of the Lysholm Knee Scoring Scale by Çelik et al. were used to subjectively determine the functional level in individuals undergoing ACL reconstruction surgery.

Control GroupStudy Group 1Study Group 2

Tegner Activity Level and the Turkish version of the Lysholm Knee Scoring Scale by Çelik et al. were used to subjectively determine the functional level in individuals undergoing ACL reconstruction surgery.

Control GroupStudy Group 1Study Group 2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Our study was conducted with 30 patients who were admitted to Medipol Mega University Hospital between 2018 and 2019 and were diagnosed with ACL rupture and required surgery.

You may not qualify if:

  • In addition to ACL injury, the patients with cartilage damage, knee arthrosis, misalignment in the lower extremity and additional ligament pathologies, history of previous knee surgery, any pathology in the opposite lower extremity, and additional neuromuscular diseases were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Gulenc B, Kemah B, Yalcin S, Sayar S, Korkmaz O, Erdil M. Surgical Treatment of Meniscal RAMP Lesion. J Knee Surg. 2020 Mar;33(3):255-259. doi: 10.1055/s-0039-1677887. Epub 2019 Mar 8.

    PMID: 30849785BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Lysholm Knee Score

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Patient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • tuğba türk kalkan, MD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 19, 2024

Study Start

December 6, 2018

Primary Completion

March 7, 2019

Study Completion

June 7, 2019

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations